Dystonia
Conditions
Keywords
dystonia, deep brain stimulation, wearable Gait Analysis
Brief summary
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
Detailed description
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
Interventions
DEVICEWearable Gait Sensor Analysis
Patients will wear inertial measurement units (IMUs) on \[specify body parts, e.g., lower back, ankles\] to record gait data during standardized walking tasks before surgery.
Sponsors
Suzhou Sceneray Medical Co. , Ltd
Beijing Pins Medical Co., Ltd
Medtronic
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed with primary or isolated dystonia. * Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery. * Able to walk independently or with assistance (sufficient to perform gait analysis). * Willing to participate and sign informed consent.
Exclusion criteria
* History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy). * Significant orthopedic issues preventing gait assessment. * Cognitive impairment preventing cooperation with study procedures. * Previous functional neurosurgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between Baseline Gait Features and BFMDRS Improvement | Through study completion, up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score | Baseline (pre-operative) and 6 months post-operative |
| Change in SF-36 Quality of Life Score | Baseline (pre-operative) and 6 months post-operative |
| Gait Characteristics (Spatio-temporal parameters) | Baseline (pre-operative) |
Countries
China
Contacts
Primary ContactLi
Outcome results
None listed